Materials Management Associate I

Materials Management Associate

At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.

The Materials Management Associate is primarily responsible for loading, kitting, transporting materials and products to and from Operational areas. Must maintain working knowledge of and participate in the coordination of and distribution of operations materials and inventory control activities. Also, this position will assist in receiving material, performing inventory cycle counts, SOP and PNS development and revision.

Essential Functions and Responsibilities

Consistently produce a high level of documentation accuracy and clarity according to cGMP documentation practices (GDP)
Receive and process GMP materials as specified
Pull and distribute released materials as requested
Maintain materials inventory
Stock supplies as needed
File materials, facilities and equipment documentation
Perform sample, materials and product shipments
Perform facility and equipment duties such as the periodic maintenance, and preventative maintenance, reporting facility and equipment problems to supervisor.
Provide suggestions for process improvements and participate in implementation
Comply with cGMP practices and regulations and safety guidelines
Participate in the Deviation and CAPA system
Provide strong customer service to internal and external customers
Observe all safety regulations and reports any unsafe working conditions to the Materials Management Supervisor/Manager

Qualifications

High School diploma/GED
Two year(s) experience in materials kitting (picking and packing)
Experience in a cGMP manufacturing environment preferred in a materials management role in a biotechnology, pharmaceutical or medical device regulated industry
Working knowledge of desktop computers and Microsoft Office applications
Working knowledge of cGMP principles with respect to FDA and EMA regulations
Working knowledge of cGCP and cGTP a plus
Must be flexible with working schedule; but, must be flexible to work weekends, when necessary.
Prior experience in a materials management role in a biotechnology, pharmaceutical or medical device regulated industry.
Biotechnology Certificate and/or cGMP experience a plus.
Working knowledge of desktop computers and Microsoft Office applications
Working knowledge of cGMP principles with respect to FDA and EMA regulations
Working knowledge of cGCP and cGTP a plus
MUST be flexible; these are day positions; but, must be flexible to work weekends, when necessary

Competencies/Candidate Profile

Strong business acumen
Ability to think strategically and tactically (detail-oriented)
Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
Analytical and problem solving skills
Ability to multi-task team is essential
Flexible and able to adapt to company growth and evolving responsibilities
Time management skills are expected
Highly organized and ability to manage multiple priorities
Ability to work independently and with various work groups
Strong attention to detail and excellent organization

Working Environment

The employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noisy.

Physical Requirements

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and /or move up to 15 pounds and occasionally lift and/or move up to 50 pounds

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.